Individualization Of Treatment; Operator's Manual; How Supplied; Compatibility - Spectranetics SLS II Mode D'emploi

8.

Individualization of Treatment

Weigh the relative risks and bene ts of intravascular catheter/lead removal procedures in cases when:
• Dual coil ICD leads are being removed;
• The lead to be removed has a sharp bend or evidence of fracture;
• The lead shows evidence of insulation disintegration raising the concern of pulmonary embolism;
• Vegetations are attached directly to the lead body.
When an outer sheath, used in conjunction with the Laser Sheath during the lead extraction procedure, is left in place once the Laser Sheath and lead are removed from the patient, the outer sheath may
then be used as a conduit for a guidewire to facilitate the implantation of a new lead.
The outer sheath tip should be either (a) fully into the atrium, or (b) retracted into the brachiocephalic vein. Placing the outer sheath tip at the SVC-atrial junction risks damage to this delicate area during
subsequent procedures, such as moving the outer sheath or implanting a new lead and is thus not recommended.
It is vital that appropriate traction be maintained on the lead being extracted both during laser assisted and standard extraction attempts. If appropriate levels of traction cannot be maintained on the
lead in order to o set the counter-pressures that distort the lead body, then changing to an alternative extraction methodology such as the femoral approach would be indicated.
When marked calci cation that moves with the lead to be extracted is seen on uoroscopy, particularly in the atrium, the availability of immediate surgical assistance is paramount if a problem presents
itself because of the extraction procedure. Also, an indication for thoracotomy removal of the lead(s) should be considered.
The safety and e ectiveness of the Laser Sheath has not been established for the following:
• Patients with recent history of pulmonary embolus
• Laser sheath advancement into the coronary sinus
9.

Operator's Manual

Energy Parameters
The devices described in this document can be operated within the following energy ranges on the CVX-300™ or Philips Laser System:
Device
12F
14F
16F
Recommended calibration settings: 60 Fluence, 40 Hz.
The laser system will allow these devices to operate for a period of 10 seconds, after which a 5 second wait will be imposed before lasing can resume.
Spectranetics SLS II Laser Sheath software requirements:
Laser System
CVX-300™ Excimer Laser System
Philips Laser System

10. How Supplied

10.1 Sterilization
For single use only. Do not re-sterilize and/or reuse.
The Spectranetics laser sheaths are supplied sterile. Sterility is guaranteed only if the package is unopened and undamaged.
10.2 Inspection Prior to Use
Before use, visually inspect the sterile package to ensure that seals have not been broken. All equipment to be used for the procedure, including the laser sheath, should be examined carefully for defects.
Examine the laser sheath for bends, kinks or other damage. Do not use if it is damaged.

11. Compatibility

Compatibility of Laser Sheath and Pacemaker/ICD Lead
The table below shows the dimensional compatibility between the Laser Sheath, the Pacemaker/ICD Lead to be removed and the Outer Sheath. It is vital that the physician determines the maximum
outside diameter (OD) of the lead before extraction with the laser sheath is attempted. This information should be obtained from the lead manufacturer.
ID = Inside Diameter
OD = Outside Diameter
Model #
Minimum Tip ID, in. / Fr /mm
Maximum Tip OD, in. / Fr / mm
Lead: Maximum OD, Fr / mm
Outer Sheath: Minimum ID, Fr/mm

12. Directions For Use

12.1 Procedure Set Up
Laser Sheath preparations:
1. Using sterile technique, open the sterile package. Remove the packaging wedges from the tray and gently lift the device from the tray while supporting the proximal coupler.
2. Connect the proximal end of the device to the connector on the laser system.
3. Calibrate the Laser Sheath following the instructions in the "Operational Modes" section of the CVX-300
the Philips Laser System Operator's Manual (P019097).
Patient preparations:
1. Obtain a thorough patient history, including patient blood type. Appropriate blood products should be readily available.
2. Ascertain the manufacturer, model number and implant date of the catheter/lead to be removed. Perform radiographic/echocardiographic evaluation of catheter/lead condition, type and
position.
3. Use a procedure room that has high quality uoroscopy, pacing equipment, de brillator, and thoracotomy and pericardiocentesis trays.
4. Prep and drape the patient's chest for possible thoracotomy; prep and drape the patient's groin for a possible femoral approach extraction procedure.
5. Establish back-up pacing as needed.
6. Have available additional Laser Sheaths, Outer Sheaths, locking stylets, stylets to unscrew active xation leads, snares (femoral workstation) and any other accessory equipment deemed necessary.
12.2 Clinical Technique
1. Patients prepared for lead extractions are prepared for multiple approaches, including an emergency cardiac surgical procedure. Preparations may include: general endotracheal anesthesia or
conscious sedation, shave and preparation of both the chest and groin areas, ECG monitoring, insertion of an arterial line and a Foley catheter, presence of instruments for pacing and de brillation,
an electrosurgical unit, and a sternal saw for emergencies.
2. A temporary pacing lead is inserted in all patients needing a pacemaker. An exception is made for patients with an implanted permanent pacemaker whose leads are not to be extracted.
3. Fluoroscopy will be used to monitor all transvenous maneuvers.
4. Expose the proximal end of the lead. Debride overgrowth from the lead as required to expose the venous entry site. Sever the lead connector and remove the anchoring sleeve.
P002674-12 21OCT20 (2020-10-21)
SLS™II Laser Sheath
Software Laser Sheath Maximum Rep Rate
V3.7XX/ V3.8XX
V1.0 (b5.0.3) and above
12F Laser Sheath
500-001
0.109 / 8.3 / 2.77
0.164 / 12.5 / 4.17
7.5 / 2.50
13 / 4.33
Fluence(mJ)
30-60
30-60
30-60
40 Hz
14F Laser Sheath
500-012
0.134 / 10.2 / 3.40
0.192 / 14.7 / 4.88
9.5 / 3.17
15.5 / 5.17
Operator's Manual (7030-0035 or 7030-0068) or the "Screen Guided Work ow" section of
™
Instructions for Use
English / English
Repetition Rate(Hz)
25-40
25-40
25-40
16F Laser Sheath
500-013
0.164 / 12.5 / 4.17
0.225 / 17.2 / 5.72
11.5 / 3.83
18.2 / 6.07
6